Ticagrelor monotherapy in patients at high bleeding risk undergoing percutaneous coronary intervention: TWILIGHT-HBR
Authors' conclusion
Among HBR patients undergoing PCI who completed 3-month DAPT without experiencing major adverse events, aspirin discontinuation followed by ticagrelor monotherapy significantly reduced bleeding without increasing ischaemic events, compared with ticagrelor plus aspirin. The absolute risk reduction in major bleeding was larger in HBR than non-HBR patients.
Study context
- Population
- High bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents, event-free after 3 months of ticagrelor plus aspirin1,064 (17.2%) HBR
- Comparison
- Ticagrelor monotherapy vs ticagrelor plus aspirin after 3-month dual antiplatelet therapy (DAPT)
- Primary endpoint
- Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding
Methodological detailsprespecified analysis, placebo-controlled
- Prespecified analysis
- Placebo-controlled
Primary result
As reported in the abstract
BARC 2, 3, or 5 bleeding, by HBR status (subgroup analysis)
Hazard ratio (95% CI)
Ticagrelor monotherapy vs Ticagrelor plus aspirinHBR: 6.3% vs 11.4%
0.53(0.35–0.82)
Ticagrelor monotherapy vs Ticagrelor plus aspirinnon-HBR: 3.5% vs 5.9%
0.59(0.46–0.77)
Difference in ARDs (95% CI)P value
HBR vs non-HBRARD −5.1% vs −2.3%
−2.8%(−6.4% to 0.8%)
P = 0.130Secondary outcomes
| Outcome | Difference in ARDs (95% CI) | P value | |
|---|---|---|---|
| BARC 3 or 5 bleeding, by HBR statusHBR vs non-HBR · ARD −3.5% vs −0.5% | −3.0% (−5.2% to −0.8%) | P = 0.008 | |
| −10−505Difference (linear scale) |
Death, MI, or stroke (key secondary endpoint)
- No significant difference between treatment arms, irrespective of HBR status
Original publication
Ticagrelor monotherapy in patients at high bleeding risk undergoing percutaneous coronary intervention: TWILIGHT-HBR. Eur Heart J. Published 18 October 2021. doi:10.
Summarised from the published abstract; every number is checked against it